# K033272: Depuy Sigma Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 5, 2004 after 118 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 51 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943462 (1994). 4 ancestors in all.
351 later devices descend from it; 4 cite it directly.
0 of 356 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 1.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 1.
- K971189: P.F.C. Sigma Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1997) Summary page 1.

## Most influential descendants
- K040166: Depuy Sigma XLK Tibial Inserts (2004), 324 descendants of its own
- K052472: Depuy Global Shoulder Crosslink Glenoid (2005), 158 descendants of its own
- K101433: Depuy Attune Knee System (2010), 114 descendants of its own
- K092122: Global Shoulder Steptech Anchor Peg Glenoid (2009), 75 descendants of its own
- K061648: Depuy Graduated Compartmental Knee (GCK) (2006), 61 descendants of its own

## Recalls of this device
- Nov 18, 2013 · Class II · Z-0418-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0421-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0419-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0417-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0416-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0420-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0412-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0422-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0414-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0415-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0413-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0423-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- May 26, 2005 · Not classified · Z-1183-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1178-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1169-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1182-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1174-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1173-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1159-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1188-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1190-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1177-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1165-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1181-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1167-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1168-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1155-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1184-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1192-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1180-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1179-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1191-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1175-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1154-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1186-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1189-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1176-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1166-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1162-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1172-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1158-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1187-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1164-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1161-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1170-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1185-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1160-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1171-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1163-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1156-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

## Indications for use
The Sigma Tibial Inserts are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

Source page: https://510kreport.com/device/K033272
Methodology: https://510kreport.com/methodology